Identity
- Trade Name
- gigasept FF (neu) EUDAMED
- Device Name
- gigasept FF new EUDAMED
- Model / Reference
- 70003415 EUDAMED70003414 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04032651984381 EUDAMED04032651984367 EUDAMED
- Basic UDI-DI
- 4032651BSC00000036AF EUDAMED
- EMDN Code
- Z12011385 CLEANING, DISINFECTION AND STERILISATION INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
gigasept FF (neu) by Schülke & Mayr GmbH — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4032651BSC00000036AF | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Schülke & Mayr GmbH
- EUDAMED SRN
- DE-MF-000005701
Sources (2)
- EUDAMED 94ba7d2b-fbd1-45fe-a836-5ec2dd336fcb 61 fields · synced Oct 6, 2026
- EUDAMED f6dbfb10-a0a8-4b15-b558-b65e52c9b24d 61 fields · synced May 18, 2026